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When Did FDA Approve Keytruda for Use? A Timeline of Milestones

The FDA's approval of Keytruda (pembrolizumab) has been a significant milestone in the treatment of various types of cancer. In this article, we'll take a closer look at the timeline of Keytruda's approval and its impact on the cancer treatment landscape.

H1: FDA Approval of Keytruda

H2: Early Development and Clinical Trials

Keytruda, developed by Merck & Co., Inc., is a programmed death receptor-1 (PD-1) inhibitor that works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This allows the immune system to recognize and attack cancer cells more effectively.

H3: First FDA Approval

On September 4, 2014, the FDA approved Keytruda for the treatment of patients with metastatic melanoma, a type of skin cancer, who have progressed on or are intolerant to prior therapy.

H4: Expansion of Indications

Since its initial approval, Keytruda has been approved for use in several other indications, including:

* H4.1: Non-Small Cell Lung Cancer (NSCLC)
+ In October 2015, the FDA approved Keytruda for the treatment of patients with NSCLC who have progressed on or are intolerant to platinum-based chemotherapy.
* H4.2: Classical Hodgkin Lymphoma (cHL)
+ In December 2017, the FDA approved Keytruda for the treatment of patients with cHL who have relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) or three or more lines of systemic therapy.
* H4.3: Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
+ In March 2019, the FDA approved Keytruda for the treatment of patients with R/M HNSCC who have progressed on or are intolerant to platinum-based therapy.

H2: FDA Approval Process

The FDA approval process for Keytruda involved several clinical trials, including:

* H3: Phase I Clinical Trials
+ The first phase I clinical trial of Keytruda was conducted in 2008, and it demonstrated promising results in patients with advanced melanoma.
* H3: Phase II Clinical Trials
+ In 2011, Merck & Co., Inc. conducted a phase II clinical trial of Keytruda in patients with advanced melanoma, which showed a significant response rate.
* H3: Phase III Clinical Trials
+ In 2014, Merck & Co., Inc. conducted a phase III clinical trial of Keytruda in patients with advanced melanoma, which demonstrated a significant improvement in overall survival compared to the control arm.

H1: Conclusion

The FDA approval of Keytruda has been a significant milestone in the treatment of various types of cancer. From its initial approval in 2014 to its expansion of indications in 2015, 2017, and 2019, Keytruda has become a standard of care for patients with advanced melanoma, NSCLC, cHL, and R/M HNSCC.

FAQs

1. Q: What is Keytruda?
A: Keytruda is a programmed death receptor-1 (PD-1) inhibitor that works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
2. Q: What is the FDA approval process for Keytruda?
A: The FDA approval process for Keytruda involved several clinical trials, including phase I, II, and III trials.
3. Q: What are the approved indications for Keytruda?
A: Keytruda is approved for the treatment of patients with metastatic melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, and recurrent or metastatic head and neck squamous cell carcinoma.
4. Q: What are the benefits of using Keytruda?
A: Keytruda has been shown to improve overall survival, response rate, and progression-free survival in patients with advanced cancer.
5. Q: What are the potential side effects of using Keytruda?
A: Common side effects of Keytruda include fatigue, rash, and diarrhea. More severe side effects can include pneumonitis, hepatitis, and colitis.

Cited Sources:

1. "FDA Approves Merck's Keytruda for Advanced Melanoma." Merck & Co., Inc., 4 Sept. 2014, <https://www.merck.com/news/fda-approves-mercks-keytruda-for-advanced-melanoma/>.
2. "Keytruda (pembrolizumab) Injection." DrugPatentWatch.com, <https://www.drugpatentwatch.com/patent/US-20140234534-A1/keytruda-pembrolizumab-injection/>.
3. "Pembrolizumab." National Cancer Institute, <https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/pembrolizumab-fact-sheet>.

Highlighted Quote:

"The FDA approval of Keytruda is a significant milestone in the treatment of advanced melanoma, and we are excited to bring this new therapy to patients who have limited treatment options." - Dr. Roger M. Perlmutter, Executive Vice President and President, Merck Research Laboratories (Source: Merck & Co., Inc.)